Description

Vernakalant Impurity 5 ((3R,1'S,2'S)-Isomer) Hcl is a specific stereoisomeric impurity of the antiarrhythmic agent Vernakalant, identified by the CAS number 795281-93-5. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this isomer during drug substance synthesis and quality assurance. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting method development, validation, and regulatory compliance for new drug applications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) and validation of testing methods.
• Drug Development & Research: Used in pharmacokinetic and metabolic studies to understand the behavior and clearance of this specific stereoisomer.
• Quality Control & Assurance (QC/QA): Essential for monitoring and controlling the levels of Vernakalant Impurity 5 in active pharmaceutical ingredient (API) batches to ensure they meet stringent purity specifications.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Method Development: Aids in developing and optimizing chromatographic separation methods to resolve Vernakalant from its stereoisomeric and process-related impurities.
• Stability Studies: Employed as a marker to track potential isomerization or degradation of Vernakalant under various stability-indicating conditions.

Basic Information

Product Name	Vernakalant Impurity 5 ((3R,1'S,2'S)-Isomer) Hcl
CAS No.	795281-93-5
Molecular Formula	C20H28N2O3 • HCl
Molecular Weight	380.91 g/mol (Free base: 344.45 g/mol)
Synonyms	(3R,1'S,2'S)-Vernakalant Impurity 5 Hydrochloride; (3R,1'S,2'S)-Isomer of Vernakalant Related Compound; (1R,2S)-rel-3-[(3R)-1-Pyrrolidinyl]-2-(2,3,4-trimethoxyphenoxy)butan-1-ol Hydrochloride; RSV-5 HCl; Vernakalant Stereoisomer Impurity; RSV-5 ((3R,1'S,2'S)-Isomer); RSR-13 Impurity (Vernakalant context)
EINECS	Contact for details

Quality Control

Every batch of Vernakalant Impurity 5 ((3R,1'S,2'S)-Isomer) Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); the container must be kept in a dry environment and sealed tightly after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Assay (on dried basis)	97.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Optical Rotation	Contact for details

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.